Trial Information
Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV
Inclusion Criteria:
- histological confirmed ovarian neoplasm
- Figo stage IIIC (2cm extrapelvic disease) or Figo IV
- more than 500 ml ascites volume (measured by sonography)
- age > 18 years old
- ECOG <= 2
- adequate hepatological, renal and haematological function
- informed consent
Exclusion Criteria:
- concomitant or previous malignant diseases
- debulking procedures on initial surgical approach
- existing peripheral sensoric neuropathy >= grade 2
- acute infections
- mental disorders, cerebral metastasis
- bowel obstruction
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Preoperative reduction of ascites volume
Outcome Time Frame:
preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)
Principal Investigator
Walther C Kuhn, Prof. MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Bonn
Authority:
Germany: Ethics Commission
Study ID:
PRIMOVAR-1
NCT ID:
NCT00551577
Start Date:
March 2003
Completion Date:
January 2008
Related Keywords:
- Ovarian Neoplasms
- Ovarian neoplasms,
- Neoadjuvant Therapy,
- Docetaxel,
- Neoplasm, Residual
- Neoplasms
- Ovarian Neoplasms